82 - The Changing Ethical Landscape for Secondary Use of Human Biological Material: Implications for Stem Cell Banking and Research

Abstract

The use of human biological material is essential for stem cell research. There is broad consensus that such use is ethically acceptable if two key conditions are satisfied: the wishes of the original donors of the material are respected and potential harms to them are minimized, in particular by protecting their privacy. What is less clear is how best to ensure that these conditions are satisfied without unduly impeding valuable research or imposing unreasonable burdens on researchers, oversight bodies, and institutions. The policies and regulations of various countries have taken slightly different approaches and some of these have been the subject of recent review and reform. For example, a notice of proposed changes to the U.S. “Common Rule” for human subjects research contains provisions that would require informed consent for use of human biospecimens, including even secondary use of non-identified material, although this could be a “broad consent” to future unspecified uses by means of an approved form. They would also require enhanced privacy and security protections for collection, storage and use of biospecimens.